FDA Adverse Event
Malfunction
Summary report: N
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
MDR report key: 2863339
·
Received December 10, 2012
Report
- Report Number
- 2015691-2012-18788
- Event Type
- Malfunction
- Date Received
- December 10, 2012
- Date of Event
- November 6, 2012
- Report Date
- November 6, 2012
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WAS REPORTED IN ERROR. UPON CLARIFICATION WITH THE EDWARDS CLINICAL SPECIALIST, IT WAS CONFIRMED THAT THIS DEVICE WAS NOT DEFECTIVE. THE PATIENT IN THIS CASE HAD A STROKE ONE DAY POST PROCEDURE. THIS WAS REPORTED UNDER MFGR.#. 2015691-2012-18789.
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSAPICAL TRANSCATHETER HEART VALVE (TAVR) PROCEDURE, THE DELIVERY DEVICE WAS NOTED TO BE DEFECTIVE. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | ASCENDRA DELIVERY SYSTEM UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |